1、Designation:F205100(Reapproved 2014)Standard Specification forImplantable Saline Filled Breast Prosthesis1This standard is issued under the fixed designation F2051;the number immediately following the designation indicates the year oforiginal adoption or,in the case of revision,the year of last revi
2、sion.A number in parentheses indicates the year of last reapproval.Asuperscript epsilon()indicates an editorial change since the last revision or reapproval.1.Scope1.1 This specification covers the requirements for single usesaline inflatable,smooth and textured silicone shell implant-ablebreastpros
3、theses,intendedforuseinsurgicalreconstruction,augmentation,or replacement of the breast.1.2 Limitations:1.2.1 This specification does not cover custom fabricatedimplantable breast prostheses.1.2.2 This specification does not cover gel/saline typeimplants,which are within the scope of Specification F
4、703.1.3 This standard does not purport to address all of thesafety concerns,if any,associated with its use.It is theresponsibility of the user of this standard to establish appro-priate safety and health practices and determine the applica-bility of regulatory limitations prior to use.2.Referenced D
5、ocuments2.1 ASTM Standards:2D412 Test Methods for Vulcanized Rubber and Thermoplas-tic ElastomersTensionD1349 Practice for RubberStandard Conditions for Test-ingD3389 Test Method for Coated Fabrics Abrasion Resistance(Rotary Platform Abrader)F604 Specification for Silicone Elastomers Used in Medical
6、Applications(Withdrawn 2001)3F703 Specification for Implantable Breast ProsthesesF748 Practice for Selecting Generic Biological Test Methodsfor Materials and DevicesF1251 Terminology Relating to Polymeric Biomaterials inMedical and Surgical Devices(Withdrawn 2012)32.2 Other Documents:USP(United Stat
7、es Pharmacopeia)4Federal Register,Title 21,Part 8205Association for the Advancement of Medical Instrumenta-tion6ANSI/AAMI/ISO 10993-1 Biological Testing of Medicaland Dental Materials and DevicesPart 1:Guidance onSelection of Tests7ANSI/AAMI/ST50-1995 Dry Heat(Heated Air)Sterilizers7ANSI/AAMI/ISO111
8、355-1994 MedicalDevicesValidation and Routine Control of Ethylene Oxide Steril-ization7ANSI/AAMI/ISO 11137-1994 Sterilization of Health CareProductsRequirements for Validation and Routine andRoutine ControlRadiation Sterilization7ANSI/AAMI/ISO 11134-1993 Sterilization of Health CareProductsRequireme
9、nts for Validation and RoutineControlIndustrial Moist Heat Sterilization7Parenteral Drug Association,1981 Technical Report No.3,Validation of Dry Heat Processes Used for Sterilizationand Depyrogenation8FDA Draft Guidance for Preparation of PMA Applicationsfor Silicone Inflatable(Saline)Breast Prosth
10、eses93.Terminology3.1 Definitions:3.1.1 fused or adhered joints(seams)sites in the shell orother parts of implantable breast prosthesis where materialshave been joined(fused or bonded)together,with or withoutadhesive,as part of the manufacturing process.1This specification is under the jurisdiction
11、of ASTM Committee F04 onMedical and Surgical Materials and Devices and is the direct responsibility ofSubcommittee F04.32 on Plastic and Reconstructive Surgery.Current edition approved Oct.1,2014.Published November 2014.Originallyapproved in 2000.Last previous edition approved in 2006 as F2051 00(20
12、06).DOI:10.1520/F2051-00R14.2For referenced ASTM standards,visit the ASTM website,www.astm.org,orcontact ASTM Customer Service at serviceastm.org.For Annual Book of ASTMStandards volume information,refer to the standards Document Summary page onthe ASTM website.3The last approved version of this his
13、torical standard is referenced onwww.astm.org.4United States Pharmacopeia,Vol XXI,Mack Publishing Company,Easton,PA1989.Available from Pharmacopeia Convention,Inc.,12601 Twinbrook Parkway,Rockville,NC 00852.5Federal Register,Vol.43,No.141,Friday,July 21,1978 Part II.Available fromU.S.Government Prin
14、ting Office Superintendent of Documents,732 N.Capitol St.,NW,Mail Stop:SDE,Washington,DC 20401,http:/www.access.gpo.gov.6Available from Association for the Advancement of Medical Instrumentation(AAMI),1110 N.Glebe Rd.,Suite 220,Arlington,VA 222014795.http:/www.aami.org.7Available from American Natio
15、nal Standards Institute(ANSI),25 W.43rd St.,4th Floor,New York,NY 10036,http:/www.ansi.org.8Available from Parenteral Drug Association(PDA),Bethesda Towers,4350East West Hwy.,Suite 200,Bethesda,MD 20814.http:/www.pda.org.9Available from Food and Drug Administration(FDA),5600 Fishers Ln.,Rockville,MD
16、 20857,http:/www.fda.gov.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 3.1.2 inflatable breast prosthesisimplantable breast pros-theses not containing silicone gel implantable breast pros-theses designed and provided prefilled with saline or empty andto be filled with saline at the time of use to adjust the volumeof the prosthesis.3.1.2.1 type1fixedvolumeinflatablebreastprosthesisan implantable breast prosthesis composed of asingle